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NCT03358979 Clinical Trial

Three-dimensional Analysis of EMMPRIN on Conjunctival Epithelial Cells Surface in Severe Dry Eye Syndrome (ALTESSE)

Dry Eye Syndromes Clinical Trial

— ALTESSE  

Official title:
Three-dimensional Analysis of EMMPRIN on Conjunctival Epithelial Cells Surface in Severe Dry Eye Syndrome (ALTESSE)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03358979
Other study ID # EGN_2017_15
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 14, 2017
Est. completion date March 2024

Study information
Verified date October 2023
Source Fondation Ophtalmologique Adolphe de Rothschild
Contact Amélie YAVCHITZ
Phone 01.48.03.64.33
Email ayavchitz@for.paris
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Modifications of cell surface markers (including EMMPRIN) were observed in conjunctival epithelial cells during dry eye syndrome ; this study aims to describe the modifications of the repartition of these cell surface markers before and after initiation of a treatment.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date March 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Patients: Inclusion criteria - 18 years and over - Severe eye dryness (grade 3 or 4) as defined by the International Dry Eye Work Shop (2007): Frequent symptoms, Impregnation of fluorescein at the conjunctival level, marked fluorescein staining at the corneal level, Tear Break Up Time = 5 seconds (fluorescein test) Schirmer's test score without anesthesia = 5mm at 5 minutes Exclusion criteria - Treatment with topical ciclosporin - Autologous serum treatment - Wearer of scleral lenses - Known pregnancy or breastfeeding Control subjects: Inclusion criteria - 18 years and over - Tear Break Up Time > 5 seconds (fluorescein test) Exclusion criteria - Wearer of contact lenses - Functional ocular signs - Anomalies of the ocular surface observed during examination with the slit lamp - Fluorescein staining of the ocular surface (cornea, conjunctiva) - Topical ocular treatment - Known pregnancy or breastfeeding

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Fondation Ophtalmologique A de Rothschild Paris

Sponsors (1)
Lead Sponsor Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary comparison of surface area of cell markers measured on conjunctival epithelial cells, in persons with and without severe eye dryness. Comparison of the mean surface in patients before treatment for eye dryness versus in persons with no eye dryness. Immunofluorescence analysed in confocal microscopy on conjunctival impression cytology. baseline
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